Drugs List

Therapeutic Indications

Uses

Short term treatment of tinea infections due to; Trichophyton rubrum, T.mentagrophytes, Epidermophyton flocossum and Microsporum canis.

Treatment of candidiasis due to Candida albicans.

Contraindications

Children under 12 years old
Facial rosacea
Acne vulgaris
Perioral dermatitis
Nappy rash
Bacterial skin infection
Viral skin infection

Precautions and Warnings

Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section.

Discontinue treatment and initiate appropriate therapy if skin irritation or sensitisation occurs.

Prolonged use on large areas of damaged skin and in skin flexures can result in local and systemic toxicity.

When used to treat children or facial areas, a single treatment course should not exceed 5 days.

Long term continuous therapy is not recommended in children of any age.

Use of occlusive dressings should be avoided.

Avoid contact with eyes.

Topical steroids should be used with caution in patients with psoriasis due to the risk of developing generalised pustular psoriasis, rebound relapses following the development of tolerance and local and systemic toxicity as a result of impaired barrier function of skin.

Pregnancy and Lactation

Pregnancy

Use with caution during pregnancy.

Avoid application of large quantities or for prolonged periods.

Animal studies with clotrimazole have shown no teratogenic effects. Foetotoxicity has been observed at high oral doses. Animal studies with corticosteroids have shown adverse effects on foetal development including cleft palate and intra-uterine growth retardation. The potential risk to humans is unknown.

Schaefer (2007) concludes that topical steroids can be used during pregnancy as long as the treatment time is brief and the area to be covered is not extensive. Whenever possible, the lowest potency of topical steroid should be selected.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution during lactation.

It is not known whether clotrimazole and betamethasone are excreted in breast milk.

It is recommended to use the least potent drug on the smallest area of skin possible and to insure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Any excess cream should be removed from the breast before nursing.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Hypersensitivity reactions
Adrenal suppression
Exacerbation of infection
Thinning of skin
Perioral dermatitis
Mild depigmentation and vellus hair
Hypertrichosis
Telangiectasia
Burning sensation
Stinging
Maculopapular rash
Oedema
Secondary infections
Erythema
Blistering
Skin peeling
Pruritus
Urticaria
Skin irritation
Folliculitis
Acne-like eruptions
Hyperpigmentation
Allergic contact dermatitis
Skin atrophy
Striae
Miliaria
Itching
Dry skin
Maceration of skin

Drugs List

Therapeutic Indications

Uses

Short term treatment of tinea infections due to; Trichophyton rubrum, T.mentagrophytes, Epidermophyton flocossum and Microsporum canis.

Treatment of candidiasis due to Candida albicans.

Dosage

Adults

Elderly

Children

Contraindications

Children under 12 years old
Facial rosacea
Acne vulgaris
Perioral dermatitis
Nappy rash
Bacterial skin infection
Viral skin infection

Precautions and Warnings

Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section.

Discontinue treatment and initiate appropriate therapy if skin irritation or sensitisation occurs.

Prolonged use on large areas of damaged skin and in skin flexures can result in local and systemic toxicity.

When used to treat children or facial areas, a single treatment course should not exceed 5 days.

Long term continuous therapy is not recommended in children of any age.

Use of occlusive dressings should be avoided.

Avoid contact with eyes.

Topical steroids should be used with caution in patients with psoriasis due to the risk of developing generalised pustular psoriasis, rebound relapses following the development of tolerance and local and systemic toxicity as a result of impaired barrier function of skin.

Pregnancy and Lactation

Pregnancy

Use with caution during pregnancy.

Avoid application of large quantities or for prolonged periods.

Animal studies with clotrimazole have shown no teratogenic effects. Foetotoxicity has been observed at high oral doses. Animal studies with corticosteroids have shown adverse effects on foetal development including cleft palate and intra-uterine growth retardation. The potential risk to humans is unknown.

Schaefer (2007) concludes that topical steroids can be used during pregnancy as long as the treatment time is brief and the area to be covered is not extensive. Whenever possible, the lowest potency of topical steroid should be selected.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution during lactation.

It is not known whether clotrimazole and betamethasone are excreted in breast milk.

It is recommended to use the least potent drug on the smallest area of skin possible and to insure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Any excess cream should be removed from the breast before nursing.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Hypersensitivity reactions
Adrenal suppression
Exacerbation of infection
Thinning of skin
Perioral dermatitis
Mild depigmentation and vellus hair
Hypertrichosis
Telangiectasia
Burning sensation
Stinging
Maculopapular rash
Oedema
Secondary infections
Erythema
Blistering
Skin peeling
Pruritus
Urticaria
Skin irritation
Folliculitis
Acne-like eruptions
Hyperpigmentation
Allergic contact dermatitis
Skin atrophy
Striae
Miliaria
Itching
Dry skin
Maceration of skin

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Reference Sources

British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London

Summary of Product Characteristics: Lotriderm cream. Pliva Pharma Ltd. Revised June 2003

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Betamethasone, Topical. Last revised: July 10, 2012
Last accessed: August 6, 2012

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Clotrimazole. Last revised: April 03, 2012
Last accessed: August 6, 2012